CA2463619C - Compositions d'azithromycine stabilisees - Google Patents

Compositions d'azithromycine stabilisees Download PDF

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Publication number
CA2463619C
CA2463619C CA002463619A CA2463619A CA2463619C CA 2463619 C CA2463619 C CA 2463619C CA 002463619 A CA002463619 A CA 002463619A CA 2463619 A CA2463619 A CA 2463619A CA 2463619 C CA2463619 C CA 2463619C
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CA
Canada
Prior art keywords
azithromycin
antioxidant
composition
stabilized
composition according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CA002463619A
Other languages
English (en)
Other versions
CA2463619A1 (fr
Inventor
Ruth Tenengauzer
Joseph Schwarz
Julia Hrakovsky
Tania Lessen
Lev Khondo
Mathi Mathivanan
Claude Singer
Michael Pesachovich
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of CA2463619A1 publication Critical patent/CA2463619A1/fr
Application granted granted Critical
Publication of CA2463619C publication Critical patent/CA2463619C/fr
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)

Abstract

L'invention concerne des compositions et des procédés de stabilisation de compositions de l'azithromycine. Les compositions d'azithromycine comprennent un adjuvant d'azithromycine et une quantité efficace stabilisante d'un antioxydant destinés à améliorer la résistance de l'azithromycine à la dégradation. La co-précipitation ou la co-concentration de l'azithromycine et d'un antioxydant sont des modes préférés de réalisation d'un adjuvant intime. L'invention concerne des formulations pharmaceutiques comprenant une composition d'azithromycine stabilisée ainsi que des procédés de production desdites formulations.
CA002463619A 2001-10-18 2002-10-18 Compositions d'azithromycine stabilisees Expired - Fee Related CA2463619C (fr)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US33634601P 2001-10-18 2001-10-18
US60/336,346 2001-10-18
US33193101P 2001-11-21 2001-11-21
US60/331,931 2001-11-21
US34129501P 2001-12-17 2001-12-17
US60/341,295 2001-12-17
PCT/US2002/033339 WO2003032922A2 (fr) 2001-10-18 2002-10-18 Compositions d'azithromycine stabilisees

Publications (2)

Publication Number Publication Date
CA2463619A1 CA2463619A1 (fr) 2003-04-24
CA2463619C true CA2463619C (fr) 2008-05-06

Family

ID=27406829

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002463619A Expired - Fee Related CA2463619C (fr) 2001-10-18 2002-10-18 Compositions d'azithromycine stabilisees

Country Status (12)

Country Link
US (3) US6764997B2 (fr)
EP (1) EP1446010B1 (fr)
AT (1) ATE428403T1 (fr)
AU (1) AU2002335087A1 (fr)
CA (1) CA2463619C (fr)
DE (1) DE60232005D1 (fr)
DK (1) DK1446010T3 (fr)
ES (1) ES2324527T3 (fr)
HU (1) HUP0402291A2 (fr)
IL (1) IL161398A0 (fr)
PT (1) PT1446010E (fr)
WO (1) WO2003032922A2 (fr)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6861413B2 (en) 2001-05-22 2005-03-01 Pfizer Inc. Stable non-dihydrate azithromycin oral suspensions
ES2258142T3 (es) 2001-05-22 2006-08-16 Pfizer Products Inc. Nueva forma cristalina.
US20080149521A9 (en) * 2001-10-18 2008-06-26 Michael Pesachovich Methods of stabilizing azithromycin
PL371259A1 (pl) * 2001-12-21 2005-06-13 Pfizer Products Inc. Bezpośrednio sprasowywalne preparaty azytromycyny
NZ532063A (en) * 2001-12-21 2006-03-31 Pfizer Prod Inc Methods for wet granulating azithromycin
RU2283092C2 (ru) * 2002-02-01 2006-09-10 Пфайзер Продактс Инк. Сухие гранулированные композиции азитромицина
CA2517004A1 (fr) * 2003-02-19 2004-09-02 Teva Pharmaceutical Industries Ltd. Procede servant a stabiliser azithromycine pendant sa conservation par emballage dans un conteneur impermeable au gaz
US20040266997A1 (en) * 2003-03-25 2004-12-30 Michael Pesachovich Degradation products of azithromycin, and methods for their indentification
BRPI0410638A (pt) * 2003-04-17 2006-06-13 Sandoz Ag derivados de azitromicina
EP1648472A2 (fr) * 2003-07-01 2006-04-26 Ranbaxy Laboratories, Ltd. Compositions orales stables de monohydrate d'azithromycine
US20050013835A1 (en) * 2003-07-15 2005-01-20 Pfizer Inc. Stable non-dihydrate azithromycin oral suspensions
CA2540104A1 (fr) * 2003-09-30 2005-04-07 Solubest Ltd. Nanoparticules hydrosolubles et leur procede de production
ES2600577T3 (es) 2003-12-04 2017-02-09 Bend Research, Inc. Procedimiento de pulverización-solidificación que usa un extrusor para preparar composiciones en multipartículas de fármacos cristalinos
US20060116336A1 (en) * 2004-03-17 2006-06-01 American Pharmaceutical Partners, Inc. Lyophilized azithromycin formulation
US7468428B2 (en) 2004-03-17 2008-12-23 App Pharmaceuticals, Llc Lyophilized azithromycin formulation
CA2591744A1 (fr) * 2004-12-21 2006-06-29 Pfizer Products Inc. Suspension orales stables d'azithromycine sous forme non dihydrate
US20060198895A1 (en) * 2005-03-07 2006-09-07 Kotliar Eleonora M Azithromycin powder for oral suspension compositions
US8906823B2 (en) * 2007-09-24 2014-12-09 Basf Corporation Pollutant emission control sorbents and methods of manufacture and use
TWI468167B (zh) 2007-11-16 2015-01-11 威佛（國際）股份有限公司 藥學組成物
US8106111B2 (en) 2009-05-15 2012-01-31 Eastman Chemical Company Antimicrobial effect of cycloaliphatic diol antimicrobial agents in coating compositions
WO2011015219A1 (fr) 2009-08-06 2011-02-10 Shifa Pharmed Industrial Group Co. Procédé de purification d'azithromycine par séparation de ses produits de dégradation thermiques et/ou isomères
RU2512683C2 (ru) 2012-06-08 2014-04-10 Общество с ограниченной ответственностью "ВИК-здоровье животных" Антибактериальная инъекционная фармацевтическая композиция
CN118105392A (zh) * 2017-04-28 2024-05-31 自由生物有限公司 治疗特应性皮炎以及提高活性药物成分稳定性的制剂、方法、试剂盒和剂型
RU2666607C1 (ru) * 2017-05-03 2018-09-11 Общество С Ограниченной Ответственностью "Вик - Здоровье Животных" Способ повышения стабильности инъекционной фармацевтической композиции
US10792262B1 (en) 2019-07-29 2020-10-06 Saol International Limited Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
US11654124B2 (en) 2019-07-29 2023-05-23 Amneal Pharmaceuticals Llc Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
CN111450065B (zh) * 2020-04-22 2022-04-01 南京嘉晨医药科技有限公司 一种阿奇霉素干混悬剂的制备方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SI8110592A8 (en) * 1981-03-06 1996-06-30 Pliva Pharm & Chem Works Process for preparing of n-methyl-11-aza-10-deoxo-10-dihydroerythromycine a and derivatives thereof
US4474768A (en) * 1982-07-19 1984-10-02 Pfizer Inc. N-Methyl 11-aza-10-deoxo-10-dihydro-erytromycin A, intermediates therefor
WO1989002271A1 (fr) * 1987-09-10 1989-03-23 Pfizer Azithromycine et derives utilises comme agents anti-protozoaires
US5605889A (en) 1994-04-29 1997-02-25 Pfizer Inc. Method of administering azithromycin
AU4399396A (en) * 1994-12-19 1996-07-10 Russinsky Limited Compounds
US5872104A (en) 1994-12-27 1999-02-16 Oridigm Corporation Combinations and methods for reducing antimicrobial resistance
CN1205338A (zh) * 1998-05-08 1999-01-20 刘万忠 阿奇霉素水溶性盐的合成新方法及其在医药上的用途
TW546302B (en) * 1998-05-08 2003-08-11 Biochemie Sa Improvements in macrolide production
US6239112B1 (en) 1998-07-09 2001-05-29 Merial, Inc. Water miscible macrolide solutions
SI20639A (sl) * 1998-11-30 2002-02-28 Teva Pharmaceutical Industries Ltd. Etanolat azitromicina, postopek za njegovo pripravo in njegovi farmacevtski sestavki
US6239113B1 (en) * 1999-03-31 2001-05-29 Insite Vision, Incorporated Topical treatment or prevention of ocular infections
IT1313610B1 (it) * 1999-08-09 2002-09-09 S I F I Societa Ind Farmaceuti Processo per la preparazione di formulazioni acquose per uso oftalmico

Also Published As

Publication number Publication date
HK1067278A1 (en) 2005-04-08
US20040192622A1 (en) 2004-09-30
EP1446010A2 (fr) 2004-08-18
ATE428403T1 (de) 2009-05-15
US20030176369A1 (en) 2003-09-18
DE60232005D1 (de) 2009-05-28
CA2463619A1 (fr) 2003-04-24
US6764997B2 (en) 2004-07-20
IL161398A0 (en) 2004-09-27
US20050106239A1 (en) 2005-05-19
DK1446010T3 (da) 2009-06-22
HUP0402291A2 (hu) 2005-03-29
PT1446010E (pt) 2009-06-08
EP1446010A4 (fr) 2007-06-13
WO2003032922A3 (fr) 2003-10-16
AU2002335087A1 (en) 2003-04-28
WO2003032922A2 (fr) 2003-04-24
EP1446010B1 (fr) 2009-04-15
ES2324527T3 (es) 2009-08-10

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